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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(k) Number K912295
Device Name KINAMED ATH 28MM ALUMINA CERAMIC LONG-NECK BALL
Applicant
Kinamed, Inc.
2000 M St. NW Suite 700
Washington,  DC  20036
Applicant Contact DANIEL J MANELLI
Correspondent
Kinamed, Inc.
2000 M St. NW Suite 700
Washington,  DC  20036
Correspondent Contact DANIEL J MANELLI
Regulation Number888.3353
Classification Product Code
LZO  
Date Received05/22/1991
Decision Date 08/12/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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